MAUDE Adverse Event Report: LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	627439301
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Livanova manufactures the customized perfusion packs.The incident occurred in usa.According to information, the lines disconnected from the reservoir of the oxygenator from competitor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova has received a report that suction lines, prime lines or lines disconnected from a competitor pediatric oxygenator during support.There is no report of any patient injury.
Additional Manufacturer Narrative
Neither pictures nor samples were available from customer.Per product ifu, the connections should be secured with a tie band.Through follow-up communication, it was clarified that the customer pushes the tubing on by hand and tie bands are not used to secure the connection.Review of complaints database revealed that no further similar event was recorded for this pts pack code.The tubing supplier natvar provides a cpk number for each roll of tubing that is shipped to livanova for the inner diameter of the tubing.These numbers are checked at receiving inspection, the values were checked again by qe and verified in specifications.Therefore, for these involved lots, no anomalies were found at incoming inspection.Based on the above facts and without the tubing samples availabe for investigation, it cannot be ruled out that the root cause of the reported event could be due to a customer suboptimal assembly of the lines.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16408297
• Report Number: 1718850-2023-00023
• Device Sequence Number: 6081595
• Product Code: DWE
• UDI-Device Identifier: 00803622148088
• UDI-Public: (01)00803622148088(240)627439301(17)240531(10)22122041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 627439301
• Device Lot Number: 2212200041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown